FDA product code KDL: Set, Perfusion, Kidney, Disposable
KDL is the FDA product code for set, perfusion, kidney, disposable. It is a Class II device, regulated under 21 CFR 876.5880 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 19 510(k) submissions under KDL, 3 in the last five years, from 14 different applicants. The average 510(k) review took 231 days (median 233); 266 days on average over the last three years. FDA has posted 4 recalls for KDL devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Set, Perfusion, Kidney, Disposable |
| Device class | Class II |
| Regulation | 21 CFR 876.5880 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for KDL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 276 |
| 2020 | 1 | 233 |
| 2021 | 1 | 188 |
| 2022 | 2 | 32 |
| 2025 | 1 | 266 |
Compare with all 510(k) review times · Search every KDL clearance
Top KDL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dr. Franz Kohler Chemie GmbH | 3 | 2020-04-24 |
| Institut Georges Lopez | 2 | 2022-06-14 |
| S.A.L.F. Spa | 2 | 2021-12-20 |
| Waters Medical Systems, LLC | 2 | 2013-08-16 |
| Bridge TO Life, Ltd. | 1 | 2025-01-24 |
9 more applicants have KDL clearances. See the full list in Caduvo.
Most recent KDL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K241239 | Bridge TO Life, Ltd. | OrganProtex HTK Solution | 2025-01-24 | 266 |
| K221386 | Institut Georges Lopez | PERF-GEN Pulsatile Perfusion Solution | 2022-06-14 | 32 |
| K221387 | Institut Georges Lopez | BEL-GEN Cold Storage Solution | 2022-06-14 | 32 |
| K211842 | S.A.L.F. Spa | Servator M SALF Solution | 2021-12-20 | 188 |
| K192408 | Dr. Franz Kohler Chemie GmbH | Custodiol HTK Solution | 2020-04-24 | 233 |
Recalls for KDL devices
4 product recalls in 4 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-01-09.
| Year | Recalls |
|---|---|
| 2024 | 1 |
Frequently asked questions
What is FDA product code KDL?
KDL is the FDA product code for set, perfusion, kidney, disposable. It is a Class II device, regulated under 21 CFR 876.5880 and reviewed by the Gastroenterology and Urology panel.
What device class is KDL?
Class II, regulation 21 CFR 876.5880. Typical premarket route: 510(k).
How long does a 510(k) take for product code KDL?
Across 19 cleared submissions the average was 231 days from receipt to decision (median 233).
Which companies have the most KDL clearances?
Dr. Franz Kohler Chemie GmbH (3); Institut Georges Lopez (2); S.A.L.F. Spa (2); Waters Medical Systems, LLC (2); Bridge TO Life, Ltd. (1).
Have KDL devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2024-01-09.
Next steps
- Run an FDA pathway report with predicate devices for product code KDL
- Run a recall and safety report across every KDL manufacturer
- Watch product code KDL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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